Blood-borne Assessment of Stromal activation in esophageAL adenocarcinoma to guide tocilizumab Therapy: a randomized phase II proof-of-concept study (BASALT)

You likely can't join if

• - Past (within 5 years) or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer, not including superficial and adequately treated skin and cervical malignancies. - Previous chemotherapy, radiotherapy and/or treatment with IL-6 receptor blockers for esophageal cancer. - Previous radiation to the mediastinum precluding full dose radiation of the currently present esophageal tumor. - Previous chemotherapy and/or treatment with targeted agents and/or IL-6 receptor blockers for other forms of cancer within the last six months. - Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. - T1N0 tumors or in situ carcinoma. - Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation. - Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery. - Pulmonary fibrosis and/or severely impaired lung function precluding major surgery. - Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine. - Dementia or altered mental status that would prohibit the understanding and giving of informed consent. - Inadequate caloric- and/or fluid intake despite consultation of a dietician and/or tube feeding. - Requires systemic treatment with IL6 receptor blockers or IL-6 antagonists, TNF-alpha blockers or other biologicals within the last six months before the first dose of trial treatment. - Has evidence of interstitial lung disease or active, non-infectious pneumonitis. - Has an active infection requiring systemic therapy which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment. - Has a total cholesterol > 6.5 mmol/L despite adequate treatment with lipid-lowering agents. - Has evidence of (latent) tuberculosis infection in patient history. - Receiving a live or live weakened vaccine during treatment with tocilizumab. - Has evidence of acute or chronic infection with hepatitis B. - Patients with prior allogeneic stem cell or solid organ transplantation. - Pre-existing motor or sensory neurotoxicity greater than WHO grade 1. - Known allergy for tocilizumab or one of its excipients (sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dehydrate).